The following data is part of a premarket notification filed by Nelmed Corp. with the FDA for Gastronomy Tube Holder.
| Device ID | K934772 |
| 510k Number | K934772 |
| Device Name: | GASTRONOMY TUBE HOLDER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NELMED CORP. 35 HAWTHORNE ST. North Attleboro, MA 02760 |
| Contact | Gordon Nelson |
| Correspondent | Gordon Nelson NELMED CORP. 35 HAWTHORNE ST. North Attleboro, MA 02760 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-05 |
| Decision Date | 1994-02-28 |